BEUDAMED
    FDA Recall Terminated

    mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.

    Recall: Z-3072-2017 · Initiated June 14, 2017

    Recall

    Recall Number
    Z-3072-2017
    Event Number
    77706
    Firm
    Medspira, Llc
    FEI Number
    3008414621
    Product Code
    GBT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 14, 2017
    Terminated
    August 24, 2021
    Address
    2718 Summer St NE, Minneapolis, MN, 55413-2820

    Description

    mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.

    Reason

    Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.

    Action

    The firm Medspira plans to contact all foreign and domestic consignees in regards to the recall. International consignees are to destroy recalled product by cutting the catheter shaft and balloon with scissors. It is also requested that their own customers be notified of the recall. Medspira plans to provide product replacement. Domestic customers are asked to return affected catheters to the recalling firm. Medspira indicates that they will cove shipping costs and replacements. All consignees are asked to complete and return the attached recall response form. For further questions please call, (612) 789-0013.

    Distribution

    Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom

    Quantity

    355 catheters (255 US - 100 foreign. )